Aktuelle Fragen bzgl. der Sicherheit der Motiva Implants®

General Questions

What are the requirements to get Motiva Implants® Breast implants?

Motiva Implants® Breast implants are indicated for the following procedures in female patients:

Breast augmentation for women of at least 18 years of age, including previous augmentation to increase the breast size and revision surgery to correct or improve the result of a previous breast augmentation surgery.

Breast reconstruction, including previous reconstruction to replace breast tissue that has been removed due to cancer or trauma, or that has failed to develop properly due to a severe breast anomaly, as well as revision surgery to correct or improve
the results of a previous breast reconstruction surgery.

Who should NOT get breast implants?

Breast implant surgery should not be performed in women with active infections anywhere in their body, with existing carcinoma of the breast (without mastectomy), with advanced ﬁbrocystic disease considered premalignant (without accompanying subcutaneous
mastectomy), with any disease clinically known to impact wound-healing ability, with tissue characteristics clinically incompatible with mammoplasty, with any condition – or treatment – determined by the surgeon to constitute an unjustiﬁable surgical
risk and women who are currently pregnant or nursing.

What complications might occur with breast implants?

Because breast implant surgery is more often performed using general anesthesia, it is associated with the same risks as other invasive surgical procedures. After breast implant surgery, patients might experience swelling, hardness, discomfort, itching,
bruising, twinges and pain over the first few weeks. Potential adverse events that may occur with silicone gel-filled breast implant surgery include capsular contracture, rupture, changes in nipple and Breast Sensation, infection, hematoma/seroma,
Delayed Wound Healing, Implant Extrusion, necrosis, granuloma, Breast Tissue Atrophy/Chest Wall Deformity, Lymphadenopathy, Gel Diffusion, Gel fracture, Anaplastic Large Cell Lymphoma (ALCL) and others. Talk to your doctor about other complications.

How long does it take the recovery process after breast augmentation surgery?

The recovery process depends on your profile and other variables. During the first 48 hours, you might have an elevated body temperature and your breasts may remain swollen and sensitive to physical contact for a month or longer. Both should fade away
over time. You are likely to feel tired and sore for several days following the operation. You could experience a feeling of tightness in the breast area as the skin adjusts to the new breast size. You should avoid any strenuous activities for at
least a couple of weeks but should be able to return to work within a few days. Breast massage may also be recommended as appropriate.

Does the breast implants Interfere with Mammography?

You should inform your examiners about the presence, type, and placement of their implants, and to request a diagnostic mammography, rather than a screening mammography. Breast implants may complicate the interpretation of mammographic images by obscuring
underlying breast tissue and/ or by compressing overlying tissue. Accredited mammography centers, technicians with experience in examining patients with breast implants, and the use of displacement techniques are needed to adequately visualize breast
tissue in the implanted breast. The current recommendations for preoperative/screening mammograms are no different for women with breast implants than for those women without implants. Pre and post-surgical mammography may be performed to determine
a baseline for routine future studies in augmentation patients.

Can I breastfeed with breast implants?

Breast implant surgery may interfere with the ability to successfully breast feed, either by reducing or eliminating milk production. Although most women with breast implants who attempt nursing have successfully breast-fed their babies, it is not known
if there are increased risks for a woman with breast implants or if the children of women with breast implants are more likely to have health problems. At this time, it is not known if it is possible for a small amount of silicone to pass from the
breast implant silicone shell into breast milk during breastfeeding, or what the potential consequences might be. A periareolar surgical approach may further increase the chance of breast-feeding difficulties. However, the American Academy of Pediatrics
has stated that there is no reason why a woman with implants should refrain from nursing.

How long do Motiva Implants® last?

Breast Implants are not lifetime devices. However, the life expectancy of a silicone breast implant cannot be precisely estimated, as there are many factors beyond the manufacturer´s control that can affect the longevity of a device. The time period varies
from patient to patient. Some patients could need replacement surgery few years after the primary procedure while others can have their implants intact for 10 years or longer. Therefore, the life expectancy of the implant cannot be guaranteed. If
you experience pain or a change in appearance please see your doctor. For safety, as well as the most beautiful and healthy outcome, it is important that you return to your plastic surgeon’s office for the follow-up evaluations prescribed by your
doctor. Yearly visits are recommended to verify the device integrity. During the 10- year follow-up visit the surgeon should assess whether or not it is advisable to remove and replace the implants.

Which Motiva Implants® will give me a round look?

Motiva Implants® Round with ProgressiveGel PLUS, provides the highest projection and a complete filling of the upper pole. For the type of results mentioned, the recommended implants should be these. However, the desired results for each
patient should be evaluated individually by the surgeon.

Which Motiva Implants® gives a more natural appearance?

Motiva Implants® Ergonomix® with ProgressiveGel ULTIMA, were designed for women who look for a breast implant that offers the most natural look and feel possible; one that adapts to their natural movements and gives them confidence
in their normal lifestyle situations. For the type of results mentioned, the recommended implants should be these. However, the desired results for each patient should be evaluated individually by the surgeon.

Based on what should I choose Silk or Velvet surface for my implants? How does it matter?

Motiva Implants® surfaces, try to mimic the cellular dimensions, enhancing the biocompatibility of the implants resulting in less abrasion and a controlled inflammatory response after breast augmentation, even in patients with active lifestyles. Therefore,
those features decrease complications after breast augmentation. Choosing one surface against the other would depend on the surgeon preferences. The most used is SilkSurface® which has the smaller surface dimensions. Other surgeons prefer VelvetSurface®
because it has a higher roughness. Both Motiva Implants® surfaces have faq-an low complications rates, less than 1%.

Motiva Implants® are divided into three categories: Round, Ergonomix and Anatomical. But what exactly is the difference?

Round implants provide a higher top and a more full-bodied appearance. They are the most common implants and are used in almost 80 percent of all breast augmentation surgeries. Anatomical implants are often called tear-drop-shaped, because they are designed
to simulate the shape of a natural breast. While the result with an anatomical implant is natural looking, the predeﬁned shape means the implant lacks natural movement and doesn’t shift with the body’s movements. As an example, see how noticeable
the lack of movement is when this patient goes from lying down to standing up. The implant retains the same shape whether the patient is prone or upright. Motiva’s Ergonomix® implants avoids this drawback using a unique gel which is very soft, allowing
the implant to follow a women’s natural movement, holding a round shape when lying down and assuming a teardrop shape when standing. This gives a very natural appearance, both in look and feel.

What is the difference between Mini/Demi/Full/Corse?

The main difference is the projection size. This means that our MINI has the smallest projection, then our DEMI, following our FULL size and the biggest projection will be our CORSE. To select the perfect size, you should contact your surgeon who is going
to select the implant projection depending on your torso and chest sizes as well as your final desired results.

Can you recommend a clinic/surgeon that uses Motiva Implants® in my country?

Where can I find more information about your products?

What is the Q Inside Safety Technology™?

The Q Inside Safety Technology is the world’s first FDA approved transponder for use in humans cleared in 2004 and the only one with CE-Mark when used in a breast implant, which consists of a biocompatible RFID (passive radio-frequency identification)
microtransponder which provides an electronic serial number that is accessed by an owned handheld reader (Motiva Q inside Reader Standard) when waved over the breast area for traceability recognition post-implantation. Motiva Implants® may or may not contain a microtranspoder. The microtransponder is a device which is placed in the breast implant filler material. This microtransponder has been separately reviewed and cleared for marketing by the U.S. Food and Drug Administration
for use as an implantable microchip that is inserted into the subcutaneous tissue of a patient to provide the patient an electronic serial number that may be used to access a database containing the patient’s identity and health information.

What are the risks associated with the microtransponder?

The risks associated with the microtransponder include the following:

Adverse tissue reaction

Migration of the transponder

Failure of the microtransponder to operate properly

Failure of the inserter

Failure of the electrical scanner

Electromagnetic interference

Electrical hazards

MRI disturbances.

These risks have been mitigated through the establishment of certain testing requirements by the FDA for this device, including the requirement to perform biocompatibility testing, migration testing, performance testing, electromagnetic compatibility
testing, electrical safety testing, and MRI compatibility testing.

What is the SN / ESN?

Breast Screening

Why are Motiva Implants® available with RFID technology?

Motiva Implants® are available with a radio-frequency identification (RFID) microtransponder embedded in the silicone gel known as the Q Inside Safety Techonology™. When interrogated by an external secure hand-held reader a
unique electronic serial number (ESN) will be transmitted by the microtransponder. With this technology Motiva Implants® assures that healthcare providers and patients have access to secure, non-invasive verification of the electronic
serial number (ESN). This unique number can then be referenced back to the implant ’s serial number, manufacturer name, date of manufacture, implant style and volume. Furthermore the ESN codes can never be lost or misplaced, unlike product and warranty
cards, providing a permanently readable code that ensures safety and well being in the event of any issue or device recall.

Are There Any Safety Concerns for Patients With Motiva Implants® with Q Inside Safety Technology?

Q Inside Safety Technology™ does not pose any safety concerns for patients. It has been proven to be both safe & effective because it tolerates all conditions to which it will be exposed. Activated externally by the reader it doesn’t
require a battery and has an indefinite life expectancy. Q Inside Safety Technology™ is Magnetic Resonance (MR) conditional per ISO Standard 14630: ”Non-active Surgical Implants”, meaning that it is a device that showed not to pose any
hazards under specific magnetic resonance conditions.

MRI scanning is the imaging modality of choice for breast implant rupture surveillance or diagnosis. In the event of a suspected rupture in Motiva Implants® with Q Inside Safety Technology™, MRI should be the first imaging of choice.
The Q Inside Safety Technology™ is a small and light device comprising of an integrated circuit and ferrite coil/antenna assembly. Due to the presence of the ferrite, an MRI of Motiva Implants® with Q Inside Safety Technology™ may produce in some of the imaging a small shadow, also known as an artifact, immediately behind the device. If a rupture is not found, but still suspected to be present in this specific area, a second imaging modality, such as CT or ultrasound,
should be employed.

What specifically causes artifacts?

Artifacts are commonplace in MRI and, may cause visualization challenges when reading tissue structures. Artifacts may be present as shadows, distortions or voids within the imaging field and can be caused by a variety of phenomena such as:

Breast implants also commonly interfere with imaging examinations by creating shadows or voids that obscures some breast tissue as well and may cause complications in obtaining a mammography of the entire breast. If you are unfamiliar with the previously
mentioned terminology and would like to learn more, please contact your doctor and / or surgeon.

What Information Needs to Be Provided to the Radiologist Prior to an MRI of Motiva Implants® with Q Inside Safety Technology™?

The radiologist should be informed of the presence of the microtransponder and that it is embedded in the interior of the breast implant. The presence of an imaging void artifact should be anticipated along with the expected size.

Are There Alternative or Additional Imaging Modalities That Will Improve Visualization of the Artifact-Affected Area?

There are other technologies that may be used in addition to MRI and are recommended complement visualization and improve overall diagnosis. Additional imaging modalities to be considered include the following:

Breast ultrasound.

Digital tomosynthesis.

Automated ultrasound.

Scintimammography.

Dual energy contrast subtraction digital mammography.

Dual-energy enhanced mammography.

If you are unfamiliar with the previously mentioned terminology and would like to learn more, please contact your doctor and / or surgeon.

Other Than Improved Imaging Visualization, Are There Any Other Benefits to Adding a Second Imaging Modality?

When clinically indicated, following an MRI scan with a second imaging modality, such as an ultrasound, may actually improve cancer detection accuracy. with or without the presence of Motiva Implants® with Q Inside Safety Technology™.

What extended warranty programs are available for Motiva Implants® with Q Inside Safety Technology™?

If a patient registers her Motiva Implants® with Q Inside Safety Technology™ within the first 90 days after implantation she will receive 1 free year extended warranty that entitles the patient for financial aid in case of
rupture or capsular contracture Baker grades III or IV, which is subject to terms, conditions and procedures. 5Y Motiva Program™ : A 5 year extended warranty program is also available for Motiva Implants® with Q Inside Safety
Technology™ registered in the Motiva website or Motiva app, only when a non-refundable fee of $200 has been paid to enroll the patient in the program. Patients must also register their Motiva Implants® with Q Inside Safety
Technology™ during the first 90 days after the initial breast surgery. Patients enrolled in the 5Y Motiva Program™, in addition to the replacement product, may also receive financial assistance for each affected implanta applicable
to the cost of the revision surgery in the case of a warranty claim for rupture or capsular contracture Baker grades III or IV, when complying to this terms, conditions and claim procedures. I also includes financial assistance for imaging testsb.

Information about warranties

Are all Motiva Implants® are covered for the lifetime of the device?

All Motiva Implants® silicone breast implants are covered by the Always Confident Warranty® against rupture for the lifetime of the device and by our Product Replacement Policy in the event of capsular contracture Baker grades
III and IV for a period of 10 years. To learn more about our Warranty Program Terms and Conditions click here.

How can I extend the coverage of my Motiva Implants®?

To extend the coverage of your Motiva Implants® silicome breast implants; Motiva offers an Extended Warranty Program that applies to qualifying Motiva Implants® silicone breast implants, through an additional fee to be covered by or on
behalf of the patient during de first 90 days after the initial breast surgery as specified below:

First Year Free Coverage. For first year coverage, patients must register their Motiva Implants® silicone breast implants through our website or through the Motiva App within the first 90 days after the initial breast surgery. Patients
with Qualified Q inside implants during this first year since implantation in addition to product replacement, in case of rupture or capsular contracture Baker grades III and IV cases, may also receive financial assistance per affected implanta applicable to the cost of the revision surgery when complying with the terms, conditions and claim procedures available in our site and app.

2Y Extended Warranty Program. The Motiva 2 year Extended Warranty Program applies only to the qualified SilkSurface® Plus without Q inside and Ergonomix® implants without Q inside registered in the Motiva website and Motiva app when a
non-refundable feed has been applied to enroll the patient in the program. Patients must register the implanted devices during the first 90 days after the initial breast surgery. For all registered products with our 2Y Motiva Program™,
in addition to the replacement product patient may also receive financial assistance per affected implantb applicable to the cost of the revision surgery for each impacted implant in the case of a warranty claim for rupture or capsular
contracture Baker grades III and IV .When complying to the terms, conditions and claim procedures available in Motiva Site and App.

5Y Extended Warranty Program. The Motiva 5 year Extended Warranty Program applies only to the qualified SilkSurface® Plus with Q inside and Ergonomix® implants with Q inside registered in the Motiva website and Motiva app when
a non-refundable feec has been applied to enroll the patient in the program. Patients must register the implanted devices during the first 90 days after the initial breast surgery. For Motiva Implants® with Q Inside Safety
Technology™, with our 5Y Motiva Program™, in addition to the replacement product customer may also receive financial assistance per impacted implanta applicable to the cost of the revision surgery in the case of
a warranty claim for rupture or capsular contracture Baker grades III and IV. When complying to the terms, conditions and claim procedures available in the Motiva Site and App.

a

£2500 / Euro Zone

€2500 / U.K.

$2500 / Rest of the world

b

£1000 / Euro Zone

€1000 / U.K.

$1000 / Rest of the world

c

£200 / Euro Zone

€200 / U.K.

$200 / Rest of the world

d

£100 / Euro Zone

€100 / U.K.

$$100 / Rest of the world

Do all the Motiva Implants® qualify for the extended 2 and 5 years warranty?

Qualified Motiva breast implant for the 2Y Extended Warranty are as follows:

Round, SilkSurface® Plus™ without Qid™

Round, VelvetSurface Plus without Qid™

Round, Ergonomix without Qid™

Qualified Motiva breast implant for Free First Year and 5Y Extended Warranty are as follows

Loss of shell integrity resulting from open capsulotomy or closed compression capsulotomy procedures.

Loss of shell integrity resulting from sharp instrument damage.

Establishment Labs may exclude from the applicable warranty program patients with previous history of capsular contracture Baker grades III and IV.

How Should I File a Warranty Claim?

To file a claim for any of our Warranty Programs or our Product Replacement Policy, Click here For all claim filing you must be accompanied by your surgeon.

Please contact the local representative or Establishment Labs Customer Service Department at customerservice@establishmentlabs.com for guidance on providing the necessary information and
support documentation BEFORE any implant is explanted.